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Trial record 25 of 28 for:    pandemrix

Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

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ClinicalTrials.gov Identifier: NCT01161160
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : August 4, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: GSK Biologicals' GSK2340274A (two different formulations)
Biological: GSK Biologicals' - GSK2340272A
Enrollment 209

Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Period Title: Overall Study
Started 76 75 58
Completed 76 75 58
Not Completed 0 0 0
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group Total
Hide Arm/Group Description Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 76 75 58 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 58 participants 209 participants
6  (2.03) 6  (2.02) 6  (2) 6  (2.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 58 participants 209 participants
Female
30
  39.5%
38
  50.7%
27
  46.6%
95
  45.5%
Male
46
  60.5%
37
  49.3%
31
  53.4%
114
  54.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 58 participants 209 participants
Asian-Central/South Asian heritage
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.5%
Asian-East Asian heritage
0
   0.0%
0
   0.0%
1
   1.7%
1
   0.5%
Asian-South East Asian heritage
76
 100.0%
74
  98.7%
57
  98.3%
207
  99.0%
1.Primary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
75
  98.7%
74
  98.7%
57
  98.3%
2.Primary Outcome
Title Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
Time Frame At Day 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
28
  36.8%
24
  32.0%
18
  31.0%
3.Primary Outcome
Title Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
75
  98.7%
74
  98.7%
57
  98.3%
4.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
25.7
(20.7 to 32)
27.1
(22.4 to 32.8)
32.2
(24.7 to 42.0)
5.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 73 74 58
Measure Type: Count of Participants
Unit of Measure: Participants
46
  63.0%
53
  71.6%
40
  69.0%
6.Secondary Outcome
Title Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
Time Frame At Day 0 and Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 73 74 58
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, Day 0
27
  37.0%
24
  32.4%
18
  31.0%
Flu A/CAL/7/09, Day 182
55
  75.3%
63
  85.1%
46
  79.3%
7.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Hide Description GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 73 74 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
6.6
(5.4 to 8.2)
8
(6.4 to 10.1)
8.9
(6.8 to 11.7)
8.Secondary Outcome
Title Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
Hide Description The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
76
 100.0%
75
 100.0%
58
 100.0%
9.Secondary Outcome
Title HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Hide Description Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
448.6
(323.9 to 621.3)
434.1
(321 to 587)
418.8
(297.6 to 589.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arepanrix 1/2 Group, Pandemrix 1/2 Group
Comments To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.
Type of Statistical Test Non-Inferiority
Comments Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.
Method of Estimation Estimation Parameter Adjusted GMT ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.73 to 1.26
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
Hide Description The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 73 74 58
Measure Type: Count of Participants
Unit of Measure: Participants
72
  98.6%
72
  97.3%
58
 100.0%
11.Secondary Outcome
Title HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Hide Description Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 73 74 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
117.4
(84.5 to 163.1)
128.3
(95.8 to 171.9)
115.7
(80.7 to 166)
12.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
41
  53.9%
41
  54.7%
23
  39.7%
Grade 3 Pain
3
   3.9%
0
   0.0%
0
   0.0%
Any Redness
0
   0.0%
1
   1.3%
0
   0.0%
Grade 3 Redness
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
1
   1.3%
5
   6.7%
1
   1.7%
Grade 3 Swelling
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C or > 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 3 to 5 years who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 33 31 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
5
  15.2%
3
   9.7%
1
   4.2%
Grade 3 Drowsiness
0
   0.0%
0
   0.0%
0
   0.0%
Related Drowsiness
1
   3.0%
2
   6.5%
0
   0.0%
Any Irritability
2
   6.1%
7
  22.6%
1
   4.2%
Grade 3 Irritability
0
   0.0%
0
   0.0%
0
   0.0%
Related Irritability
0
   0.0%
2
   6.5%
0
   0.0%
Any Loss of appetite
6
  18.2%
4
  12.9%
1
   4.2%
Grade 3 Loss of appetite
1
   3.0%
1
   3.2%
0
   0.0%
Related Loss of appetite
1
   3.0%
2
   6.5%
0
   0.0%
Any Fever
2
   6.1%
5
  16.1%
5
  20.8%
Grade 3 Fever
1
   3.0%
2
   6.5%
1
   4.2%
Related Fever
1
   3.0%
5
  16.1%
2
   8.3%
14.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 6 to 10 years who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 41 44 33
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
4
   9.8%
3
   6.8%
2
   6.1%
Grade 3 Fatigue
1
   2.4%
0
   0.0%
0
   0.0%
Related Fatigue
1
   2.4%
0
   0.0%
0
   0.0%
Any Gastrointestinal
2
   4.9%
1
   2.3%
0
   0.0%
Grade 3 Gastrointestinal
1
   2.4%
0
   0.0%
0
   0.0%
Related Gastrointestinal
0
   0.0%
0
   0.0%
0
   0.0%
Any Headache
7
  17.1%
9
  20.5%
4
  12.1%
Grade 3 Headache
1
   2.4%
0
   0.0%
0
   0.0%
Related Headache
0
   0.0%
2
   4.5%
0
   0.0%
Any Joint pain at other location
5
  12.2%
1
   2.3%
4
  12.1%
Grade 3 Joint pain at other location
1
   2.4%
0
   0.0%
0
   0.0%
Related Joint pain at other location
1
   2.4%
0
   0.0%
0
   0.0%
Any Muscle aches
6
  14.6%
7
  15.9%
5
  15.2%
Grade 3 Muscle aches
0
   0.0%
0
   0.0%
0
   0.0%
Related Muscle aches
1
   2.4%
1
   2.3%
0
   0.0%
Any Shivering
4
   9.8%
2
   4.5%
0
   0.0%
Grade 3 Shivering
1
   2.4%
0
   0.0%
0
   0.0%
Related Shivering
0
   0.0%
0
   0.0%
0
   0.0%
Any Sweating
2
   4.9%
1
   2.3%
0
   0.0%
Grade 3 Sweating
1
   2.4%
0
   0.0%
0
   0.0%
Related Sweating
0
   0.0%
0
   0.0%
0
   0.0%
Any Fever
4
   9.8%
0
   0.0%
0
   0.0%
Grade 3 Fever
1
   2.4%
0
   0.0%
0
   0.0%
Related Fever
1
   2.4%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With Medically-attended Adverse Events (MAEs)
Hide Description MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time Frame Up to day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
14
  18.4%
9
  12.0%
1
   1.7%
16.Secondary Outcome
Title Number of Subjects With MAEs
Hide Description MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time Frame During the entire study period (Day 0 to Day 182)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
29
  38.2%
29
  38.7%
18
  31.0%
17.Secondary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame Up to Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Subjects With pIMDs
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame During the entire study period (Day 0 to Day 182)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame Within the 21-day (Days 0-20) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
22
  28.9%
21
  28.0%
5
   8.6%
20.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame Within the 42-day (Days 0-41) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
28
  36.8%
28
  37.3%
23
  39.7%
21.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Up to 21 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the entire study period (Day 0 to Day 182)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description:
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 76 75 58
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
0
   0.0%
1
   1.7%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
Adverse Event Reporting Description The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
 
Arm/Group Title Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Hide Arm/Group Description Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
All-Cause Mortality
Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%)   0/58 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/76 (1.32%)   0/75 (0.00%)   1/58 (1.72%) 
Infections and infestations       
Dengue fever  1  1/76 (1.32%)  0/75 (0.00%)  0/58 (0.00%) 
Influenza  1  0/76 (0.00%)  0/75 (0.00%)  1/58 (1.72%) 
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/76 (68.42%)   52/75 (69.33%)   35/58 (60.34%) 
Eye disorders       
Conjunctivitis (Days 0-41 post-vacc.)  1  3/76 (3.95%)  1/75 (1.33%)  3/58 (5.17%) 
General disorders       
Pyrexia (Days 0-20 post-vacc.)  1  2/76 (2.63%)  6/75 (8.00%)  1/58 (1.72%) 
Pyrexia (Days 0-41 post-vacc.)  1  4/76 (5.26%)  9/75 (12.00%)  6/58 (10.34%) 
Pain  1  41/76 (53.95%)  41/75 (54.67%)  23/58 (39.66%) 
Swelling  1  1/76 (1.32%)  5/75 (6.67%)  1/58 (1.72%) 
Drowsiness (3-5Y)  1  5/33 (15.15%)  3/31 (9.68%)  1/24 (4.17%) 
Irritability (3-5Y)  1  2/33 (6.06%)  7/31 (22.58%)  1/24 (4.17%) 
Loss of appetite (3-5Y)  1  6/33 (18.18%)  4/31 (12.90%)  1/24 (4.17%) 
Temperature/Axillary (3-5Y)  1  2/33 (6.06%)  5/31 (16.13%)  5/24 (20.83%) 
Fatigue (6-10Y)  1  4/41 (9.76%)  3/44 (6.82%)  2/33 (6.06%) 
Headache (6-10Y)  1  7/41 (17.07%)  9/44 (20.45%)  4/33 (12.12%) 
Joint pain (6-10Y)  1  5/41 (12.20%)  1/44 (2.27%)  4/33 (12.12%) 
Muscle aches (6-10Y)  1  6/41 (14.63%)  7/44 (15.91%)  5/33 (15.15%) 
Shivering (6-10Y)  1  4/41 (9.76%)  2/44 (4.55%)  0/33 (0.00%) 
Temperature/Axillary (6-10Y)  1  4/41 (9.76%)  0/44 (0.00%)  0/33 (0.00%) 
Infections and infestations       
Upper respiratory tract infection (Days 0-20 post-vacc.)  1  5/76 (6.58%)  5/75 (6.67%)  1/58 (1.72%) 
Nasopharyngitis (Days 0-20 post-vacc.)  1  5/76 (6.58%)  1/75 (1.33%)  2/58 (3.45%) 
Rhinitis (Days 0-20 post-vacc.)  1  4/76 (5.26%)  2/75 (2.67%)  0/58 (0.00%) 
Nasopharyngitis (Days 0-41)  1  7/76 (9.21%)  5/75 (6.67%)  5/58 (8.62%) 
Upper respiratory tract infection (Days 0-41 post-vacc.)  1  6/76 (7.89%)  6/75 (8.00%)  3/58 (5.17%) 
Rhinitis (Days 0-41 post-vacc.)  1  5/76 (6.58%)  2/75 (2.67%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough (Days 0-41 post-vacc.)  1  2/76 (2.63%)  4/75 (5.33%)  3/58 (5.17%) 
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01161160     History of Changes
Other Study ID Numbers: 114495
First Submitted: July 1, 2010
First Posted: July 13, 2010
Results First Submitted: March 3, 2017
Results First Posted: August 4, 2017
Last Update Posted: September 6, 2018